Our company is seeking a Quality Operations Compliance Specialist to join our team. As a key member of the quality operations function, you will play a vital role in ensuring that all products meet the required standards for marketed and investigational drug products.
Key Responsibilities:
* Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance
* Review/Audit of completed Batch Records
* Review of Manufacturing Logs as required
* Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)
* Completion of Incoming Raw Material checks, including product status maintenance (as required)
* Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required)
* Administration of Quality Logs, e.g. QA Hold, Sample Request
* Lead operations floor daily walk around of manufacturing areas
* Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times
Essential Requirements:
* Third level degree in a science, quality or engineering discipline
* Ideally previous experience in a quality role
* A minimum of three years' experience in a quality/operations role in a highly regulated GMP environment
Benefits:
* Opportunity to work in a dynamic and growing industry
* Chance to develop your skills and expertise in quality operations
* Competitive salary and benefits package
Others:
The ideal candidate will have a strong knowledge of regulatory requirements and be able to adapt to new requirements. They will also possess excellent communication and problem-solving skills. If you are a motivated and detail-oriented individual who is passionate about quality and compliance, we encourage you to apply for this exciting opportunity.